Regulatory Project Manager - Diegem, Belgium

Regulatory Project Manager - Diegem, Belgium

The Manager, EU Regulatory Affairs develops and implements regulatory strategies and processes to assure efficient processes and documentation of new requirements for CSS products in compliance with applicable Regional Regulations and international standards:

Leverage deep knowledge of the regulatory environment, including compliance, current and proposed laws regulations, standards, directives, guidance, Notified bodies position paper.

Provides strategic guidance to CSS to assure efficient processes and documentation of new requirements for CSS products o Provides advice, counsel and expertise on RA and compliance issues in a team environment, both proactively as well as reactively

Assists the RA platform for any questions related to the new requirements and develop recommendations pertinent to the CSS portfolio o Ensures vigilance of Environmental regulations and their outcomes for CSS products

Provides training on new regulations to the RA platform on his/her topics of expertise

Represents CSS in various internal and external forums for the platform o Serves as a consultant, making recommendations and corrective actions, and supports audits from a regulatory perspective (internal and external)

Authorizes shipment of pre-CE marked devices for clinical studies

Partners closely with internal partners across Johnson & Johnson to ensure well defined regulatory strategies for products launch and modifications o Notifies RALI and EU Registration Team representative to ensure timely registration of new products launch and products modifications

Approves ECO's pertaining to the Manager's projects and duties (including but not limited to SOPs, EU labeling approval)

Reviews EMEA internal and external communications that reference products and/or disease state information in accordance with EU regulations (Copy Review Process)

Controls the distribution of medical devices in accordance their regulatory requirements and registration status (item restriction)

Supports customization activities in the European Distribution Center (Late Stage Customization o process)

Responsible for communicating business related issues or opportunities to next management level

Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures o Responsible for defining training curriculums assignments for associates

Responsible for communicating business related issues or opportunities to next management level

Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

QUALIFICATIONS:

Bachelor's degree with experience or PhD, Pharm, Masters, legal degree with adequate experience required.Advanced degrees and education in medicine, engineering, science or law preferred.

Adequate experience in EU regulatory requirements for medical devices required.

KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:

Strategic thinking and ability to partner and Influence key stakeholders.

Expert knowledge of regulatory requirements in the EU and ability to translate regulations into clear data requirements to support EU registrations

Ability to persuasively communicate with EU authorities

Highly skilled in establishing partnerships with regional colleagues

A strong results-orientation and sense of urgency

Fluent in English and in another European language

Acute analytical skills and sharp regulatory interpretation abilities

Tactful attitude towards customers

Assertiveness - problem solving Conscientious

Connect by cultivating external relationships with EU authorities, notified body and internally collaborating with the Platform commercial organization

Shape by anticipating and influencing product specific guidelines and standards.

Lead by providing guidance to a team of talented regulatory professionals and transparently communicating in a constructive manner

Deliver by mobilizing and shaping requirements in technical documentation to deliver results for on-time EU registrations

Additional information about the process

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.